阿拉善盟药监系统体制改革研究

发布时间：2018-12-16 00:29

【摘要】：现如今,人民生活水平日益提高,药品安全也越来越受到公众的重视,几乎每年都会发生药品安全事件,这些事件严重危害到人民的身心健康和生命安全。也因此,药品安全监管走入公众视线,并成为关注焦点。“铬超标胶囊事件”、中草药安全事件层出不穷,这些事件将我国药品监管的薄弱面暴露无遗。国家和地方政府都在不断探索适应当今形势的较为成熟的监管模式。国家食品药品监管体系通过历次变革以日渐成熟,但许多边远地区如阿拉善盟在改革过程中还存在许多问题。本文通过分析国外药品监管体制优势,回顾我国食品药品监管体制历次改革情况,对阿拉善盟药监系统改革案例进行分析,找到了从中央到地方存在的普遍问题,从而提出适应阿拉善盟的药监改革模式。必须对权力进行重新分配,转变职能才能够实现体制改革,而转变政府职能是行政改革的重要内容。由市场自主进行优化配置,使政府机构改革同经济社会的发展相互适应,政府负责宏观调控,依照法律规范进行行政活动。我国传统医药的重要组成部分之一即为民族医药。在国家的大力扶持下,民族医药蓬勃发展,并形成了相当一部分颇具规模的民族医药企业和专家队伍。但是由于历史和客观因素制约,传统蒙医药在步入现代化、集约化发展的进程中困难重重。本文依据阿拉善盟实际对蒙医药发展各个环节进行了全面详实的调查了解,并在客观分析研究的基础上,找出了阿拉善盟蒙医药产业现状的关键问题及潜在优势。本文提出阿拉善盟的蒙医药产业发展,要打破长久以来的传统思维,避免进行低水平重复；走出留不住专业人才的怪圈,加大投入,大力培养蒙医药专业人才；打破现有的状况,将生产设备进一步整合、更新,以适应日益增长的蒙药市场需求。本文围绕的主题是药品监管体制改革,将研究分为六个部分。第一部分是导论,阐明了研究背景、研究意义,提出了研究方法、研究思路,并对国内外监管体制研究进行分析。第二部分是对相关概念包括药品监管概念、法治政府概念、依法行政概念进行简述。第三部分是分析国家药品监管系统体制改革情况,分析国家食品药品监管总局历年来机构改革情况。第四部分是对阿拉善盟2014年药监体制改革进行分析总结。第五部分是对全国药监系统普遍存在的问题进行总结,并提出阿拉善盟药品监管本身存在的问题。第六部分提出阿拉善盟药监系统发展的对策和蒙医药产业发展及监管对策。
[Abstract]:Nowadays, people's living standard is improving day by day, and drug safety is paid more and more attention by the public. Almost every year, drug safety incidents occur, which seriously endanger people's physical and mental health and life safety. Therefore, drug safety supervision and control into the public eye, and become the focus of attention. "Cr exceeds the standard capsule event", the Chinese herbal medicine safety incident emerges one after another, these incidents expose the weak aspect of the medicine supervision in our country. State and local governments are constantly exploring more mature regulatory models to adapt to the current situation. The national food and drug regulatory system has matured through successive changes, but in many remote areas, such as Alashan League, there are still many problems in the process of reform. By analyzing the advantages of foreign drug supervision system and reviewing the past reform of food and drug supervision system in China, this paper analyzes the case of drug supervision system reform in Alashan League, and finds out the common problems from the central to the local level. Thus, the reform mode of drug supervision adapted to Alashan League is put forward. It is necessary to redistribute the power and transform the function to realize the system reform, and the transformation of the government function is the important content of the administrative reform. The government is responsible for macro-control and administrative activities in accordance with the laws and regulations, so that the reform of government institutions and the development of economy and society can be adapted to each other. One of the important components of traditional medicine in China is national medicine. With the strong support of the state, the national medicine flourished and formed a considerable number of national medicine enterprises and experts. However, due to historical and objective factors, traditional Mongolian medicine is facing difficulties in the process of modernization and intensive development. According to the actual situation of Alashan League, this paper makes a comprehensive and detailed investigation and understanding of every link of Mongolian medicine development, and on the basis of objective analysis and research, finds out the key problems and potential advantages of the current situation of Mongolian medicine industry in Alashan League. This paper puts forward that the development of Mongolian medicine industry in Alashan League should break the traditional thinking for a long time, avoid low level repetition, step out of the strange circle of not retaining professional talents, increase investment, and vigorously train Mongolian medical professionals. Break the existing situation and further integrate and update the production equipment to meet the increasing demand of Mongolian medicine market. This paper focuses on the reform of drug regulatory system and divides the research into six parts. The first part is an introduction, which clarifies the research background and significance, puts forward the research methods, research ideas, and analyzes the domestic and foreign regulatory system research. The second part is a brief description of the related concepts, including the concept of drug regulation, the concept of government by law and the concept of administration by law. The third part is to analyze the reform of the national drug regulatory system and the institutional reform of the State Administration of Food and Drug Administration over the years. The fourth part is the analysis and summary of the reform of drug surveillance system in Alashan League in 2014. The fifth part summarizes the problems in the national drug surveillance system, and points out the problems in Alashan League. The sixth part puts forward the countermeasures of the development of drug surveillance system in Alashan League and the development and supervision of Mongolian medicine industry.
【学位授予单位】：内蒙古大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F203

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